Healthy Skepticism Library item: 13433

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Publication type: Journal Article

Sale of infant cough medicines splutters to a halt
The Lancet 2008 Apr 5; 371:(9619):1138
http://www.thelancet.com/journals/lancet/article/PIIS0140673608604973/fulltext

Abstract:

The UK Medicine and Healthcare products Regulatory Agency (MHRA) announced last week that over-the-counter cough medicines are no longer suitable for children younger than 2 years, following recent advice from the US Food and Drug Administration (FDA). Six medicines marketed towards this age group, but also available for older children, have been removed from general sale pending relabelling. A selection of antihistamines, antitussives, expectorants, and decongestants found in cough medicines are associated with a risk of serious adverse events caused by dosing errors in children younger than 2 years due to their small size …

Unfortunately, both the MHRA and FDA regulations fail to address the fundamental issue that the effectiveness of cough medicines has not yet been proven in children of any age. The fact that the UK and USA are still deliberating whether these medicines are suitable for older children is remarkable, considering that the January, 2008, Cochrane Review of randomised controlled trials spanning the past 40 years, concluded that “there is no good evidence for or against the effectiveness of over-the-counter medicines in acute cough”. The MHRA calls itself a “leading contributor” in improving the availability of medicines suitable for children, but it has disappointingly failed to act in this case. Until there is evidence that cough medicines are effective in children, they should be removed from sale altogether.

Keywords:
Antitussive Agents/economics* Antitussive Agents/poisoning Cause of Death Child Child, Preschool Cough/drug therapy* Drug Industry/legislation & jurisprudence Drugs, Non-Prescription/economics* Drugs, Non-Prescription/poisoning Great Britain Humans Incidence Infant Infant Mortality Infant, Newborn Marketing/legislation & jurisprudence* Overdose/epidemiology United States

Notes:

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